The systems and processes life sciences have traditionally used to manage quality have become inadequate. However, while current external conditions require manufacturers to adapt and change, they also have a new opportunity to formulate a strategy that creates market differentiation and improves operational and financial performance. The new strategy must align quality with success by design, and transform quality and quality data into a competitive asset. The forward-thinking life sciences enterprise will achieve it by digitalizing data, connecting the digitalized data to related business and operational systems, and applying analytics to identify new insights. This research report addresses life sciences challenges and how market leaders approach them today. Specifically, it examines: How rising world populations and standards of living increase spending on healthcare Pressures from the USFDA and other regulatory bodies to satisfy cGMP regulations and quality expectations Why a shift from traditional quality is necessary to address new expectations and improve corporate success How to execute a structured, successful Quality 4.0 journey Real-world examples of Quality 4.0 from leading batch and process companies Actions life sciences companies can take right now to lay the groundwork for Quality 4.0